ACTONEL Drug Patent Profile
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When do Actonel patents expire, and when can generic versions of Actonel launch?
Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs.
The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and eighty-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
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Summary for ACTONEL
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 87 |
| Clinical Trials: | 35 |
| Patent Applications: | 2,193 |
| Drug Prices: | Drug price information for ACTONEL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ACTONEL |
| What excipients (inactive ingredients) are in ACTONEL? | ACTONEL excipients list |
| DailyMed Link: | ACTONEL at DailyMed |
Recent Clinical Trials for ACTONEL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dong-A ST Co., Ltd. | Phase 4 |
| Wake Forest University Health Sciences | Phase 3 |
| Weill Cornell Medicine | Phase 4 |
Pharmacology for ACTONEL
| Drug Class | Bisphosphonate |
Paragraph IV (Patent) Challenges for ACTONEL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ACTONEL | Tablets | risedronate sodium | 150 mg | 020835 | 1 | 2008-08-12 |
| ACTONEL | Tablets | risedronate sodium | 75 mg | 020835 | 1 | 2007-09-07 |
| ACTONEL | Tablets | risedronate sodium | 5 mg, 30 mg and 35 mg | 020835 | 1 | 2004-04-23 |
US Patents and Regulatory Information for ACTONEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-001 | Mar 27, 1998 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Warner Chilcott | ACTONEL WITH CALCIUM (COPACKAGED) | calcium carbonate; risedronate sodium | TABLET;ORAL | 021823-001 | Aug 12, 2005 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-005 | Apr 22, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ACTONEL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-003 | May 25, 2002 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-004 | Apr 16, 2007 | ⤷ Sign Up | ⤷ Sign Up |
| Apil | ACTONEL | risedronate sodium | TABLET;ORAL | 020835-002 | Apr 14, 2000 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ACTONEL
See the table below for patents covering ACTONEL around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 9810027 | ⤷ Sign Up | |
| Spain | 2226128 | ⤷ Sign Up | |
| Austria | 195075 | ⤷ Sign Up | |
| Spain | 2253136 | ⤷ Sign Up | |
| South Africa | 9805010 | ⤷ Sign Up | |
| South Korea | 20090106663 | BISPHOSPHONIC ACID FOR THE TREATMENT AND PREVENTION OF OSTEOPOROSIS | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ACTONEL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1175904 | C01175904/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: SCHERING CORPORATION, US |
| 0998292 | CA 2006 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
| 1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
| 1175904 | CA 2007 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
| 0998292 | 91222 | Luxembourg | ⤷ Sign Up | 91222, EXPIRES: 20200824 |
| 0186405 | C300031 | Netherlands | ⤷ Sign Up | PRODUCT NAME: RISEDRONINEZUUR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF FARMACEUTISCH AANVAARDBARE ESTER, IN HET BIJZONDER NATRIUMRISEDRONAAT; NAT REGISTRATION NO/DATE: RVG 24990 20000609; FIRST REGISTRATION: SE 15290 - 15297 19991007 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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